Could a poop pill help your heart?
NCT ID NCT07490054
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether replacing unhealthy gut bacteria with healthy donor bacteria (via capsules) is safe and doable for people with chronic heart failure. About 40 adults with stable heart failure will take the capsules and be monitored for side effects and adherence. The goal is to see if this approach, already used for infections, might help manage heart failure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Reduced Ejection Fraction (HFpEF), New York Heart Association Class II-IV * On stable treatment for CHF for one month prior to enrollment * Able to swallow capsules * Able to provide blood sample and fecal sample * Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence. Exclusion Criteria: * Dysphagia to pills * Clinically active inflammatory bowel disease * History of celiac disease * Listed for transplant, and anticipated transplant listing or LVAD placement in the next 6 months * Acute myocarditis * Infiltrative and hypertrophic cardiomyopathies * Renal disease requiring dialysis * Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential at the screening visit or day 1 (prior to the receipt of IMT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive IMT treatment. Patients will be counseled to avoid pregnancy which is the standard of care for patients with CHF. * Life expectancy of \< 6 months * Presence of ileostomy or colostomy * Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors). * Patients with neutropenia (an absolute neutrophil count \< 0.5 x 109 cells/L) obtained on a complete blood count with differential at screening * History of solid organ or bone marrow transplant * Anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis) * History of severe anaphylactic food allergy * Patients receiving cancer chemotherapy, immunotherapy, or radiation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
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